According to court documents, ghostwriters for Wyeth wrote 26 articles that appeared in 18 different medical journals between 1998 and 2005 emphasizing that hormones protect against osteoporosis, heart disease and dementia and down-playing the risks. In 2001, Wyeth benefited by reaping nearly $2 billion in sales of its HRT drugs Premarin and Prempro, making them among of the most prescribed drugs in the U.S.

But at what cost did Wyeth benefit?

In 2002, the Women’s Health Initiative (WHI), a research initiative initiated by the National Institutes of Health to look into some of the major health problems of older women, was abruptly halted after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. One of the thousands of victims is Geraldyne Frambs of Sacramento, Calif.

In the mid-1980s, Frambs was prescribed and began taking HRT. In 2003, she was diagnosed with breast cancer. Now she wants justice. This week, attorney Ted G. Meadows with Beasley Allen Law Firm filed a lawsuit on behalf of Frambs against Wyeth Inc., Weyth Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC, Pharmacia Corporation, Pharmacia & UpJohn LLC, Greenstone Ltd, Barr Laboratories Inc., Barr Pharmaceuticals and ESO Lederle Inc.

The lawsuit alleges that the cancer, subsequent surgery, treatment, injury and damage to Frambs were caused by her use of HRT. The complaint alleges that the defendants were negligent by not assuring that their products did not cause users to suffer from foreseeable unreasonably dangerous side effects and serious health problems, and that they should have known the serious risks women were put under by using drugs that were defective at the time of production. Furthermore, the complaint alleges that the defendants willfully deceived the plaintiff by concealing the true facts concerning the hormone therapy drugs, which the defendants, as manufacturers, marketers and distributors of the products, had a duty to disclose to the plaintiff.

The lawsuit seeks recovery of all monies the plaintiff paid for the products; to be compensated for the cost of medical care as a result of the use of the products including past medical expenses, wage loss, pain, suffering, disability and emotional distress.

Read Frambs’ complaint: Frambs v Wyeth (HRT Lawsuit)

Sources:
New York Times
Beasley Allen

SOURCE: Hormone Replacement Therapy › Wyeth paid ghostwriters to sway doctors to prescribe HRT

“Even though this share seems low, ovarian cancer remains highly fatal, so accordingly this risk warrants consideration,” the researchers, led by Lina Steinrud Morch of Copenhagen University, wrote.

The risk of ovarian cancer from hormone replacement therapy remained steady among variables such as duration of use, formulation of hormones, estrogen dosage, or how it was administered. Earlier studies, however, suggested cancer risk diminished about two years after therapy was stopped.

The findings add fuel to the Women’s Health Initiative (WHI) study that was halted in 2002 after data suggested the use of HRT put women at a much greater risk for breast cancer, ovarian cancer, strokes and cardiovascular disease. Those findings contradicted the claims of HRT makers, who told physicians the hormones actually warded off such conditions.

Since the WHI findings became public, use of HRT has dropped considerably. Since 2001, drug maker Wyeth has experienced a 50 percent drop in sales of its HRT Prempro, and has been faced with numerous lawsuits from women harmed by the drug.

Sources:
Reuters
New York Times

SOURCE: Hormone Replacement Therapy › Study: HRT puts women at greater risk for ovarian cancer

The study, conducted by researchers at Northern California Cancer Center in Fremont, tracked overall incidence of invasive breast cancer from 2001 to 2004, and noted that the rate of breast cancer fell by 13.8 percent in urban areas but by only 7.5 percent in rural areas. Neighborhoods in high-income areas also reported 13 percent fewer incidence of breast cancer compared to a 9.6 percent decline in poor counties.

Breast cancer reports in rural counties peaked in 1999 and then steadily declined while breast cancer reports in urban counties didn’t reflect significant decline until after 2002. In 2002, the Women’s Health Initiative abruptly halted its trail on postmenopausal women and HRT after data indicated women on HRT were at greater risk for serious health concerns, in particular breast cancer.

Authors of the Cancer Center study say that the pattern of decline in the rate of breast cancer in rural versus urban counties is “consistent with the changing pattern of (HRT) prevalence and cessation or noninitiation.”

The study also indicated that breast cancer was most likely diagnosed in urban areas versus suburban or rural communities. While HRT appears to be the primary cause, the authors caution that some changes could be explained by “saturation or decreases in mammographic screening.”

Source: MedPage Today

SOURCE: Hormone Replacement Therapy › Greater reduction in HRT/breast cancer rates in urban, affluent towns

Attorneys for the research center argued that the data, which is the most recent information collected in a follow up of the Women’s Health Initiative (WHI), had not yet been analyzed, peer-reviewed or published and that allowing Wyeth to sort through the raw data was simply “preposterous.” The Cancer Research Center had been resisting Wyeth’s requests for the information through subpoenas but will now have to surrender the data.

WHI, conducted by the Department of Health and Human Services, National Institutes of Health, and the National Heart, Lung and Blood Institute, was launched in 1991 and consisted of a set of clinical trials and an observational study that involved more than 160,000 generally healthy postmenopausal women. The major 15-year research program was designed to address the most common causes of death, disability and poor quality of life in postmenopausal women – cardiovascular disease, cancer and osteoporosis.

Preliminary results of the 2002 WHI showed that women who took HRT to relieve symptoms of menopause were at an even greater risk for serious diseases and conditions such as breast cancer, ovarian cancer, cardiovascular disease, stroke and blood clots.

As a result of the study, numerous lawsuits have been filed against makers of HRT, including Wyeth. To date, there are about 8,000 plaintiffs with cases pending against Wyeth, of which 7,000 plaintiffs are part of the multidistrict litigation that falls under Wilson’s pretrial oversight.

Source: NWAnews.com

SOURCE: Hormone Replacement Therapy › Judge orders WHI follow-up data be released to Wyeth

There is a mad dash among pharmaceutical companies worldwide to find a drug that safely treats the symptoms of menopause. Premarin, after all, was the best selling HRT in the U.S. before the Women’s Health Initiative (WHI) in 2002 linked HRT to higher incidences of breast cancer, heart attacks and strokes. Since then, the use of HRT has drastically reduced, and similarly, so has the incidence of breast cancer among menopausal women.

Despite the urgency in finding a safer alternative to HRT, experts say it will take at least four years for the synthetic hormones to become available. And it would expensive. Drugs for human use typically cost about $1 billion to develop. The next step would be finding an effective way to communicate to women that the synthetic hormones are actually safe, a tough job considering the bad rap HRT has received since WHI.

SOURCE: Hormone Replacement Therapy › Researchers working on safer synthetic HRT for menopause

The news is just another blow to Prempro, a combination of estrogen and progestin that was widely prescribed to women as a treatment for menopausal symptoms. Prempro and other HRTs were once thought to improve a woman’s health as she entered postmenopausal years; however, results from a Women’s Health Initiative (WHI) shook that belief when the findings of that study revealed women on HRT were at an increased risk of breast cancer and cardiovascular disease. Since 2002, when the findings were released, sales of HRT medications like Prempro have plummeted and lawsuits against companies like Wyeth have escalated.

According to the new trial, which reviewed women from WHI age 50 to 79, after five years on Prempro 67 women died from non-small cell lung cancer compared with 39 on a placebo. The study group included both current and former smokers.

“This is a new finding that tells us women who smoke shouldn’t take estrogen and progestin for menopause symptoms,” said Rowan Chlebowski, the study author and a researcher at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.

According to the study, among the women classified as current or former smokers, there were 56 deaths among women taking hormones and 34 deaths among women on a placebo. Among the women classified as nonsmokers, there were 9 deaths for women on HRT and 5 deaths for those taking a placebo.

Source: Bloomberg.com

SOURCE: Hormone Replacement Therapy › Prempro increases risk of dying from small cell lung cancer

Researchers at Medco Health Solutions Inc. studied an estimated 1,300 women and found that women who were taking antidepressants such as Paxil, Prozac or Zoloft along with tamoxifen for at least one year had a breast-cancer recurrence rate of 16 percent. Women who were not taking the drugs reported a 7.5 percent recurrence rate. Antidepressants such as Celexa, Lexapro and Luvox appeared not to have an increased cancer recurrence rate.

Tamoxifen is a commonly used treatment for estrogen-dependent breast cancer, one of the most common types of breast cancer and one that has been associated with the use of hormone replacement therapy, HRT.

“If we lower the effectiveness of tamoxifen, you’d get worse outcomes.” Says Dr. Julie Gralow, an associate professor in oncology at the University of Washington School. She says many doctors in the U.S. also prescribe aromatase inhibitors rather than tamoxifen to block estrogen in post-menopausal women to prevent breast cancer from returning, which also avoids the tamoxifen-antidepressant interaction.

An estimated 30 percent of the half million American women taking tamoxifen have also been prescribed antidepressants. Medco says it has found that some doctors who treat breast cancer patients are not aware of the increased recurrence risk for breast cancer patients taking tamoxifen and antidepressants.

Source: The Wall Street Journal

SOURCE: Hormone Replacement Therapy › Tamoxifen with antidepressants may raise risk of breast cancer recurrence

The study published this week in the Epidemiology journal refutes the notion that a family history contributes to the carcinogenic effects of estrogen.

“Although we know that family history is a risk factor, we don’t know yet what it is about family history that conveys the risk,” said Robert E. Gramling, M.D., D.Sc., assistant professor of Family Medicine and of Community and Preventive Medicine at URMC. “Some have proposed that it might be an increased sensitivity to estrogen, but our data did not support that notion. In fact, this study suggests the causal pathway based on family history is probably not estrogen sensitivity.”

Family history is identified as a “first-degree family history,” involving breast cancer in a mother, sister or daughter. Both family history and estrogen therapy have independently been identified as a risk factor for postmenopausal women. The Rochester study focused on whether the two risk factors together increased a woman’s risk.

Researchers used data from the Women’s Health Initiative randomized trial, which followed 16,608 premenopausal women who took HRT or a placebo pill between 1993 and 2002. The study was halted after data began to show that HRT greatly increased a woman’s risk of breast cancer, heart disease and other serious illness.

SOURCE: Hormone Replacement Therapy › HRT-breast cancer risk same regardless of family history

Last February, the New England Journal of Medicine concluded that HRT was in fact linked to a surge of breast cancer cases and that women who took a combination of progestin and estrogen for more than five years doubled their risk of breast cancer – a statistic far greater than originally thought. It also showed that a typical 50-year-old woman has less than a 1 percent chance of developing breast cancer, and if she takes HRT for less than four years, her risk of breast cancer drops back down to normal. Also, HRT now contains far less estrogen and progestin.

The new information gives women who are having a difficult time suffering through the symptoms of menopause the opportunity to make a more educated decision about whether to take HRT. Dr. Marcia Stefanick, a professor of medicine at Stanford University, says that before making a decision a woman should assess whether she is at high risk for breast cancer.

Women who are considered high risk for breast cancer include those with a family history of the disease, women who have had children after the age of 30 or have never had children, and women who started menstruating before age 11. Age is also a factor, as older women are at higher risk for the disease.

SOURCE: Hormone Replacement Therapy › More studies help women make educated decisions about HRT

Prior to the initiative in 2002, more than 200,000 American women were diagnosed with breast cancer each year. After 2002, that rate dropped below 190,000 each year since. Statistics from other countries show similar results.

Despite the findings, some researchers aren’t convinced the drop is due to a decrease in hormone use. For one, mammography was increasing in the late 1990s, enabling physicians to detect breast cancer earlier than before. This is an argument favored by Joseph Camardo, senior vice president of global medical affairs for Wyeth, the maker of hormone replacement drug Prempro. Wyeth is facing lawsuits from more than 11,000 women who took Prempro. Other critics of the campaign against HRT say that the drop was far too sudden to be linked to to the WHI findings.

The new study is a response by doctors involved in WHI who stand firm on their belief that HRT lead to serious health risks for women.

“These are non-conventional analyses, but I think this is the best data we have,” Rowan Chlebowski, a University of California, Los Angeles doctor who led the new study, was quoted in the news story. “This really suggests there’s a great benefit to women for stopping, because the risk goes down almost immediately.”

SOURCE: Hormone Replacement Therapy › Drop in breast cancer rates linked to reduction of HRT use

Iowa Sen. Charles E. Grassley, a member of the Senate Finance Committee, is leading the investigation into the drug industry’s influence on doctors. As part of the investigation, Sen. Grassley has sent letters to Wyeth and DesignWrite, a medical writing company, asking for details on scientific reports that were prepared by DesignWrite for Wyeth and to describe the authors’ extent of involvement and any fees paid.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Sen. Grassley wrote to Wyeth’s chairman and chief executive, Bernard J. Poussot, according to the New York Times story.

Prempro was one of the more widely used hormone replacement therapies prescribed for women to combat symptoms of menopause, such as hot flashes, night sweats, mood swings and decreased sexual desire. It was thought that hormones had an added benefit – that taking HRT reduced a woman’s chance of breast cancer and heart disease. However, the Women’s Health Initiative in 2002 found that taking HRT measurably increased a woman’s risk for serious conditions including breast cancer, ovarian cancer and heart disease. Since then, Wyeth has faced numerous lawsuits claiming the drug company misled the public about the safety of its hormone therapy.

SOURCE: Hormone Replacement Therapy › Study finds Wyeth paid ghostwriters to promote Prempro

Years ago, HRT was the method-of-choice for most women to combat annoying menopausal symptoms such as hot flashes, moodiness, night sweats and decreased sexual desire. The therapy also was thought to offer other benefits, such as a lowered risk of heart disease and breast cancer.

However, the Women’s Health Initiative (WHI) of 2002 changed popular opinion when it found that HRT greatly increased a woman’s risk of breast cancer, heart disease and other serious illnesses. Since then, HRT and its effects have continued to be a closely studied therapy.

University of California-Irvine senior statistician, Sarah F. Marshall, presented the findings of her study at the San Antonio (Texas) Breast Cancer Symposium. The study followed 2,800 postmenopausal women who developed breast cancer beginning in 1995 until their deaths or through the end of 2005.

It found that women who took HRT before they were diagnosed with cancer were more likely to be diagnosed with estrogen receptor-positive cancer, and that the cancer was smaller and detected at an earlier stage. Marshall says that this type of cancer – estrogen receptor-positive cancer – is easier to treat and as a result, women have a lower risk of dying.

SOURCE: Hormone Replacement Therapy › Estrogen receptor-positive cancer easier to treat, study says

Most doctors prescribed HRT for women experiencing bothersome symptoms of menopause such as hot flashes and night sweats, mood swings and decreased sexual desire. Just a few years ago it was believed that long-term use of HRT was safe and offered other benefits, such as protecting against osteoporosis and heart disease.

However, preliminary results of the 2002 Women’s Health Initiative (WHI) showed that the complications of HRT far outweighed the benefits. WHI researchers found that women on hormones were at an even higher risk for serious diseases and conditions such as breast cancer, ovarian cancer, cardiovascular disease, stroke and blood clots.

The new study is the first follow up to the landmark WHI. The analysis focused on women’s health three years after stopping HRT. Researchers have found that women who stopped HRT still had an increased risk of cancer – especially breast and lung cancers. The report also found a decreased risk of heart disease.

During the second and third years after the end of WHI, researchers noticed that women who took hormones but stopped were 24 percent more likely to develop cancer than women who had taken placebos during WHI.

Researchers say the analysis results show that women who have stopped taking hormones need to be vigilant about getting cancer screenings and mammograms.

SOURCE: Hormone Replacement Therapy › Cancer risk still elevated even years after stopping HRT

Hot flashes and night sweats are a common symptom of menopause in most women. While the cause is unknown, researchers believe those symptoms are due to changing levels of estrogen on the temperature regulation centers of the brain. According to the report, when estrogen levels drop during menopause, it triggers the body to release heat, making the woman experience a hot flash. Since body fat is insulating, researchers believe that women with more body fat may have a hard time dissipating body heat when hot flashes occur. Thus, the hot flashes tend to last longer.

Overweight women also tend to have higher circulation levels of estrogen, which was initially thought to reduce the impact of hot flashes. Higher estrogen circulation can help reduce the risk of osteoporosis, but also can increase a woman’s risk of breast and uterine cancers.

Because menopausal symptoms can become bothersome, many women turn to hormone replacement therapy (HRT). HRT was a common treatment for menopausal symptoms however more women are opting to go without or seek alternatives to HRT after the Women’s Health Initiative of 2002 showed that HRT increased a women’s risk of serious health conditions such as breast cancer and heart disease.

Some studies suggest that exercise may help alleviate some symptoms of menopause, such as hot flashes and night sweats. Considering the study recently published in the American Journal of Epidemiology, perhaps reducing body fat can also reduce the duration of hot flashes.

SOURCE: Hormone Replacement Therapy › Heavier women suffer more hot flashes, study suggests

The usual symptoms of a heart attack are what he describes as a “crushing chest pain radiating to the arm and/or jaw.” The symptoms often are associated with shortness of breath and sweating. However, he warns, those “typical” symptoms are not so common in women, with as many as 40 percent of women reporting that they never even experienced chest pain during a heart attack, also known as a myocardial infraction, or MI.

Dr. Hersh explains that women most often have “prodromal symptoms,” or symptoms for up to a month before having a heart attack. The warning symptoms include unusual fatigue, sleep disturbances, shortness of breath, a feeling of indigestion, and anxiety. During an MI, women often experience symptoms such as a hot or burning sensation in their back (above the waist), shoulders, arms or lower jaw that is often sensitive to the touch. Other unusual symptoms include shortness of breath; overwhelming fatigue; severe nausea or vomiting; dizziness or fainting; weakness in the arms; a sudden feeling of anxiety, panic or impending doom; and occasionally chest pain and other “typical” symptoms.

Menopause, on the other hand, carries symptoms such as hot flashes that typically start in the face and chest and then become generalized; sleep disturbances, which are often due to the hot flashes; and fatigue and depression. The common symptoms, Dr. Hersh points out, often are played out differently. For example, hot flashes that start all over the face and become generalized may be more likely to be due to menopause as opposed to a hot sensation in the lower jaw.

Heart disease is the No. 1 cause of death in women, so women with any concerning symptoms should address them with their doctor. And if you experience symptoms of an MI, call 911 or go directly to the emergency room. Early treatment can save your life.

SOURCE: Hormone Replacement Therapy › Menopause, heart attack symptoms sometimes can be similar

Wyeth Pharmaceuticals caught wind of the book and its author’s claims that estrogen reduced a woman’s risk for both breast and genital cancers, and began distributing the book to physicians across the country. Soon after, sales of Wyeth’s HRT drug Premarin took off, growing to more than 30 million prescriptions each year.

But the Women’s Health Initiative of 2002 showed dramatically different results, finding the use of hormone replacement therapy linked to an increased risk of breast cancer, cardiovascular disease, heart attacks and blood clots.

This is the basis of at least 22 federal lawsuits that have been filed over a period of two days against Wyeth, according to The West Virginia Record.

“The WHI and NCI studies released in July 2002 changed the way doctors and scientists viewed estrogen – not only does estrogen hormone therapy fail to prevent disease, it substantially increases the risk of causing disease,” the suit states.

The plaintiffs claim they suffered bodily injury, pain and suffering, disability, disfigurement, mental anguish and the loss of their capacity to enjoy life. The suit contends that Wyeth should be held liable because it did not perform adequate pre-clinical testing nor did it conduct post-marketing surveillance to determine the product’s safety. Wyeth also did not provide adequate warnings of long-term use of HRT, instead continuing to market its medication to physicians, according to the lawsuit.

The 13-count lawsuit seeks unspecified compensatory and punitive damages.

SOURCE: Hormone Replacement Therapy › Wyeth faces more lawsuits for promoting sales despite concerns

The link was discovered during the Women’s Health Initiative (WHI), a major 15-year research program launched in 1991 to address the most common causes of death, disability and poor quality of life in postmenopausal women – cardiovascular disease, cancer and osteoporosis. The study was halted prematurely because participants on HRT exceeded the boundary for breast cancer risk that was established at the beginning of the study. There also was an increased risk for heart disease for patients on HRT compared to those who were not.

But a new report published online Tuesday in the Journal of the National Cancer Institute found that cases of breast cancer had fallen 2.2 percent between 1999 and 2002, several years before hormone replacement therapy became an issue, meaning other factors may be involved, according to the Houston Chronicle.

Overall, the report pointed to a first-time drop in the cancer rates among both men and women, according to the story. It also showed a dramatic drop in the 15-year decline in cancer death rates, meaning people diagnosed with cancer are living longer. Researchers credit aggressive cancer prevention and treatment efforts for the successes in the fight against the country’s No. 2 killer.

SOURCE: Hormone Replacement Therapy › Report cites drop in cancer rates among men and women

The research revealed that women with no existing heart conditions who took HRT experienced negative heart health effects, including inflammation which can be related to heart disease.

The study was prompted by researchers who wanted to know the validity of the so-called six-week timing hypothesis, a theory which came about following the Women’s Health Initiative which linked the use of HRT to an increased risk of heart disease and other serious diseases and conditions. The timing hypothesis suggests that if a woman begins HRT within six years of her final menstrual period, the drugs could keep heart disease from developing at the onset of menopause.

While the six-week window found HRT showed beneficial changes in HDL and LDL cholesterol levels, the risk of heart disease was still a viable threat, according to researchers. Thus, women are encouraged to discuss their options with their doctors in order to make a decision they are comfortable with.

Heart disease risk can be measured with lipid panels and by measuring inflammation markers. These tests typically are not conducted as part of an office visit for women considering hormone replacement therapy.

SOURCE: Hormone Replacement Therapy › Researchers find HRT can have negative effect on heart health

According to the story, attorney General Catherine Cortez Masto said in a news release, “When drug companies purposefully misrepresent the safety and efficacy of their drugs, or promote their drugs in a deceptive way, everybody loses. We’re confident we have the facts necessary to prove this case, and we hope this lawsuit and its outcome will deter improper drug company practices in Nevada.”

The suit claims that the drug company misled Nevada patients and their doctors about the safety and the effectiveness of the drugs Premarin, Prempro and Premphase, sold by Wyeth; and Provera, sold by Pfizer. That, the suit contends, resulted in the over-prescribing and drastic increase in hormone-positive cancers in women who had taken the drugs. The suit seeks $5,000 to $12,000 in damages for each violation.

Weyth’s HRT drugs Premarin and Prempro dominated the market for menopausal symptoms. However, since the Women’s Health Initiative of 2002, which found HRT increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its drugs Premarin and Prempro.

Last year, three Navada women won $58 million in compensatory and punitive damages after claiming Prempro caused their breast cancer. Wyeth also was ordered to pay $1.6 million in attorney fees. The drug maker has appealed the verdict to the Nevada Supreme Court.

SOURCE: Hormone Replacement Therapy › Nevada AG sues companies for misleading about HRT safety

Researchers found that women who took the breast cancer drugs were 30 percent less likely to have their cancer return over the next nine years. The drugs essentially starve potential cancers of estrogen, which can cause menopause-like symptoms in the women who take them. While the side effects may be discouraging, they may also be showing how well the treatment is working.

Researchers looked at 4,000 post-menopausal women who took AstraZeneca’s Arimidex, also known as anastrozole, or tamoxifen. Arimidex can only be taken by women who already have gone through menopause. The study showed that women who reported the menopause-like side effects within three months of treatment were more likely to remain cancer free.

Breast cancer is one of the most common forms of cancer among women, and the second most common cause of cancer death among women. According to Breast Cancer: Network of Strength, female breast cancer incidence rates continuously increased for two decades, but have leveled off since 2001. The organization theorizes that one possible explanation for the decrease is that millions of women stopped taking hormone replacement therapy (HRT) following the Women’s Health Initiative of 2002, which indicates a positive link between taking HRT and developing breast cancer.

SOURCE: Hormone Replacement Therapy › Hot flashes, sweats from anti-cancer drugs may be good sign

Researchers from the University of Queensland’s School of Population Health in Brisbane studied data from the Australian Longitudinal Study on Women’s Health, which compiled information beginning in 1996. From that, the researchers pulled data collected from nearly 1,000 women born between 1946 and 1951, both before and after hysterectomies. What they found was that hysterectomies performed on women older than 45 to 50 years of age did not lead to greater weight gain. However, the study did show that overweight women with a body mass index between 25 and 30, were more likely to have hysterectomies.

The study supports the concern of health care providers that obesity leads to more chronic health concerns.

Where and how a woman lives also may affect hysterectomy rate, according to the report. Women from rural communities or lower socioeconomic backgrounds had a higher rate of hysterectomy compared to women from urban communities or higher socioeconomic upbringings. Researchers theorize that hysterectomies were more often considered “quick fixes” for various health problems in rural environments and in communities where there are more barriers to access to regular care.

Research also has found that women from those backgrounds are more likely to have children at younger ages and thus more likely to accept hysterectomies than women who choose to have children later in life.

The study is published in Menopause: The Journal of the North American Menopause Society.

SOURCE: Hormone Replacement Therapy › Australian study finds hysterectomies do not cause weight gain

Premarin is a low-dose mixture of estrogen hormones and is already available in pill form to treat symptoms of menopause such as hot flashes and vaginal dryness, burning and itching. Premarin and another Wyeth drug prescribed for menopausal symptoms, Prempro, dominated the hormone replacement therapy market until the Women’s Health Initiative of 2002 linked long-term use of HRT to an increased risk of breast cancer and other serious health problems. Wyeth has since been faced with numerous lawsuits concerning the drugs.

Dyspareunia is a disorder that follows the atrophy or thinning of the vagina and vulva, a condition that can occur in menopause.

The .5-gram cream has two dosing regiments – 21 days on followed by 7 days off, or twice weekly. FDA approval of the cream and its dosing regime was granted based on results from a multi-center clinical study that included a 12-week, randomized, double blind placebo phase followed by a 40-week open-label phase, according to the story.

Wyeth advises women considering the cream to review possible side effects with their physician, and to avoid the product if they fall into a high-risk category.

SOURCE: Hormone Replacement Therapy › FDA approves Premarin cream to treat dyspareunia

During menopause, sex drive can drop to very low levels, which some believe may be a result of lowered levels of estrogen, progesterone and testosterone in the body during menopause. Estrogen helps you to feel heightened sensitivity during sexual intercourse. Progesterone keeps your libido up. Testosterone boosts sexual desire and lubricates the vagina.

For relief from menopausal symptoms, women typically have been prescribed hormone replacement therapy (HRT), which is a medication containing female hormones such as estrogen. More and more women and their doctors are shying away from HRT as a result of recent studies which have found the use of HRT places women at a higher risk for breast cancer as well as other serious conditions.

The FDA has not approved the use of testosterone for low sexual function, though off-label use is allowed.

According to FoodConsumer.org, a Study by Swiss researchers titled “breast cancer risk in postmenopausal women using testosterone in combination with hormone replacement therapy” found that testosterone patches used for 24 weeks more than doubled monthly sexual episodes in women with low sexual desire and activities. However, in the one-year trail, breast cancer was diagnosed in four of the 534 women treated with the testosterone compared to none in the 277 women who were taking placebos.

Researchers concluded that “at present, there are no valid randomized or observational clinical studies that provide evidence that the addition of testosterone to conventional postmenopausal hormone therapy influences breast cancer risk.”

SOURCE: Hormone Replacement Therapy › Male hormone increases sex drive, cancer risk questionable

Perimenopause is the body’s natural transition toward menopause. This is period leading up to menopause – anywhere from two to eight years – as well as the first year after a woman’s last menstrual cycle.

Many women may not realize they can feel the symptoms of menopause long before menopause occurs. However, as many as 80 percent of women have reported experiencing menopausal symptoms years before they enter menopause.

There is no way of knowing when perimenopause starts or how long it will last. Women usually experience perimenopause in their 40s, though some experience it as early as their mid 30s.

During perimenopause, a woman’s estrogen levels rise and fall unevenly. Menstrual cycles may lengthen or shorten and women start having cycles where they don’t ovulate. They also may begin experiencing hot flashes, mood swings, sleep problems, vaginal and bladder problems, changes in sexual function and bone loss.

Therapies – such as oral contraceptives and IUDs – are available to quell the physical symptoms of perimenopause and regulate periods. AsiaOne quoted Dr Christopher Ng, a consultant obstetrician and gynecologist at GynaeMD Women’s and Rejuvenation Clinic at Camden Medical Centre, who encourages patients to focus on good nutrition and regular exercise, to adopt a low-fat, high-fiber diet rich in calcium, and to avoid alcohol and caffeine, which can trigger hot flushes.

Good nutrition is key at this point in a woman’s life as declining estrogen levels may lead to serious conditions. For example, diminishing estrogen levels may lead to an increase in low-density lipoprotein (LDL) cholesterol – also known as the “bad cholesterol” – as well as a decrease in high-density lipoprotein (HDL) cholesterol – or “good cholesterol” – both of which contribute to an increased risk of heart disease.

SOURCE: Hormone Replacement Therapy › Women can experience symptoms years before menopause

According to the study, women who have never given birth had, per child, a two percent adjusted increase in the risk of having a hip replacement and an eight percent increase of knee replacement. Current use of HRT was associated with a 38 percent increase in hip replacement and a 58 percent increase in knee replacements. There was no explanation why there was a greater risk of hip replacement over knee replacement.

The study also found that women who had their first period at or before age 11 were nine percent more likely to have a hip replacement and 15 percent more likely to have knee replacement compared to women who started their periods after age 11. Researchers also found that past use of oral contraceptives had no relationship to hip or knee replacements.

The researchers noted that estrogen is well known to prevent bone loss, however past research is divided as to whether estrogen is damaging to cartilage.

SOURCE: Hormone Replacement Therapy › Study finds HRT may increase need for hip, knee replacements

If only there was some way of knowing when our reproductive cycles will end.

Last week, Australian news.com.au reported that researchers at the University of Michigan have developed a new test that can tell women how many years they are away from menopause, offering, as they put it, “a road map to their reproductive life.”

The research, which followed 600 women over 14 years, looked at changes in the hormones FSH and inhibin B, which stimulate eggs. Researchers found that the two hormones dropped significantly five years prior to menopause.

Researchers also tracked another 50 women for changes in the hormone AMH, a hormone that helps predict fertility. They found that AMH also fell to a very low or non-measurable level five years before final menstruation.

The University of Michigan research team says the findings can help women who choose to have babies later in life make important decisions about their future. However, Australian experts say it offers false hope.

According to the news story, Australian researchers dismiss the findings, arguing that similar studies have been done in Australia but have yet to produce conclusive results. “I do not believe it’s possible at this time to accurately predict (menopause),” says Australian Menopausal Society endocrinologist Henry Burger.

SOURCE: Hormone Replacement Therapy › Test may help women know when menopause is approaching

The changes, which go into effect immediately, are part of “Project Impact,” a restructuring plan announced by Wyeth in January that cuts 10 percent – or about 5,000 – of its workforce. As part of Project Impact, the company will narrow its focus to find more successful new drugs especially those for which no good treatments are available. Thus, it will scale back from research on 55 diseases to only 27.

Wyeth’s new focus will be on vaccines; cancer; inflammatory disorders such as rheumatoid arthritis, severe asthma and lupus; metabolic conditions such as diabetes and obesity; musculoskeletal disorders such as arthritis and spinal fracture; and neuroscience such as Alzheimer’s and Parkinson’s disease, depression, schizophrenia and chronic pain, according to the report.

Since the Women’s Health Initiative, which found hormone replacement therapy increased a woman’s risk for breast cancer and other serious diseases and conditions, Wyeth has been faced with numerous lawsuits over its hormone replacement drugs Premarin and Prempro, which dominated the market for menopause symptom treatments for years.

According to the report, Wyeth will continue with late-stage testing on experimental menopause drugs Aprela and Pristiq. (Currently, the FDA has demanded additional research data on Pristiq.) A study of 3,400 women indicated no evidence of increased breast cancer rates. Wyeth plans to submit Aprela for FDA approval in the second half of 2009.

SOURCE: Hormone Replacement Therapy › Wyeth to stop making HRT, focus on cancer research

Bone scans are used to check for osteoporosis, a disease in which bones become fragile and more likely to break. Women are typically four times more likely than men to suffer from osteoporosis. Because there is a direct relationship between the lack of estrogen after menopause and the development of osteoporosis, most doctors advise older women to have bone density tests every year along with a mammogram.

The University of Arizona’s eight-year study of 10,000 post-menopausal women found that the results of a routine bone density test not only could reveal osteoporosis, it also may provide important clues in predicting breast cancer risk in older, post-menopausal women. The study, which looked at hip-bone mineral density T-score, found older women with high bone density twice as likely to develop breast cancer.

“High bone density is a marker of increased risk for breast cancer. We can use that piece of information to predict your breast cancer risk in the future,” said Zhao Chen, Ph.D, MPH, University of Arizona epidemiologist.

Bone density often means a higher production of estrogen, which researchers say may explain the correlation between high bone density and breast cancer risk.

Conversely, KABC-TV reports that some osteoporosis medications have been shown to prevent and even curtail breast cancer. For example, raloxifene (Evista) has already been FDA approved to treat both osteoporosis and prevent breast cancer in postmenopausal women at high risk of developing the disease.

SOURCE: Hormone Replacement Therapy › Strong bones in menopause may increase risk of breast cancer

To further complicate matters, ovarian cancer is hard to diagnose in its early stage. Only about 20 percent of ovarian cancer is found at the early stage. When found early, the survival rate is 95 percent over five years. Approximately 75 percent of ovarian cancer cases are diagnosed at an advanced stage after the cancer has spread beyond the ovary.

But a new method devised by researchers at the Fred Hutchinson Cancer Research Center in Seattle, Wash., has been found to increase the diagnosis of the disease by one third, according to FoodConsumer.org. The process used both a questionnaire on symptoms and blood tests. Using the questionnaire alone led to the discovery of early stage ovarian cancer in 60 percent of the cases. The blood test alone reported to same percentage of results. However, both the questionnaire and the blood test combined resulted in an early stage diagnosis in 80 percent of the cases.

Symptoms include bloating, pelvic and abdominal pain, difficulty eating or feeling full quickly, and urinary urgency or frequency. Additional symptoms may include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities. Blood tests to diagnose ovarian cancer include the CA-125. Other diagnostic tests include physical exam, pelvic exam, ultrasound and biopsy.

SOURCE: Hormone Replacement Therapy › New method found to detect early stage ovarian cancer

Those who practice acupuncture say that the therapy can remedy a host of women’s health issues, particularly fertility, pregnancy support and menopause. While the holistic healthcare discovered in Asia more than 3,500 years ago is gaining popularity in the Western world, getting the world out has been challenging. In an effort to raise awareness, the National Certification Commission of Acupuncture and Oriental Medicine has deemed today and every October 24th National Acupuncture & Oriental Medicine Day.

The National Center for Complementary and Alternative Medicine, an outreach of the National Institutes of Health, one-third of adults in the United States uses some form of alternative medicine, according to the Ventura County (California) Star. The most common practices are acupuncture, acupressure, herbal medicine, tai chi and gi gong.

For Myerson, acupuncture was a godsend. After a few visits of targeted pin pushing, she felt like a new woman. And her night sweats stopped. But hard evidence that the practice actually does work is still inconclusive. The American Medical Association says there is little evidence for it to confirm the safety or efficacy of most alternative therapies. But some doctors and patients claim, if acupuncture helps relieve chronic symptoms, like uncomfortable and disruptive night sweats from menopause, then it is worth consideration.

SOURCE: Hormone Replacement Therapy › Acupuncture an alternative therapy for menopause

Earlier this week, as part of October’s international breast cancer awareness month, leaders from Liaquat National Hospital in Pakistan addressed the issue and their concern over why so many Pakistani women are still unaware of the disease, according to the Daily Times.

Sixty-eight percent of Pakistani women living in urban areas have breast cancer as opposed to 32 percent of Pakistani women living in rural areas. Oncologists blame the lack of awareness and information about the treatment for breast cancer, citing women’s concern that chemotherapy causes hair loss and biopsies will help the disease spread. They also argue that free mammograms would encourage more women to seek medical attention and thus aid in early detection.

According to the story, 10 percent of Pakistani women are at risk for breast cancer, but few are aware of the risk factors for the disease.

Aga Khan University Hospital Associate Professor of Haematology and Oncology, Dr Nihal Masood, in her lecture on at the conference said that there is a greater than 50 percent spread of breast cancer in the country for younger women. “Therefore, every doctor, medical student and informed people should convey this message to elder women of their families so they are examined,” according to the report.

SOURCE: Hormone Replacement Therapy › Pakistani women still unaware of breast cancer risk

According to the report, Kings College London researchers tracked 442 female breast cancer survivors for more than four years, half of which had been given HRT. The women who were taking HRT had a 14 percent higher recurrence rate than those who did not take HRT.

All women tracked participated in the 2002 U.S. government-sponsored Women’s Health Initiative, which studied the effects of HRT on women. That study was halted after researchers found that HRT led to an increased risk of dangerous medical conditions such as breast cancer, heart attack, stroke and blood clots.

In a related commentary in the Journal of the National Cancer Institute, Dr. Kathy Prichard of Canada’s Sunnybrook Odette Cancer Center, indicated that the data is convincing. “It seems that the harmful side effects of HRT (in breast cancer survivors) have finally been clearly demonstrated in what is, by today’s standards, a small randomized trial, carried out in a few relatively small countries,” Dr. Pritchard wrote.

SOURCE: Hormone Replacement Therapy › HRT linked to recurrence of breast cancer

For six years, Danish researchers tracked nearly 700,000 healthy Danish women aged 51 to 69. While researchers found no increased risk of a heart attack in women who were currently using HRT compared with women who had never used HRT, there was a 24 percent increased risk among women aged 51 to 54, and an increased risk in women of the same age group taking the prescribed medications for a long period of time.

The study found that older women taking HRT over the long term did not have an increased risk of heart attack; however there was an increased risk among these women with estrogen alone.

The Danish study is the largest of its kind since the 2002 U.S. government-sponsored Women’s Health Initiative (WHI), that was halted when researchers found that HRT led to an increased risk of dangerous conditions such as breast cancer, heart attack, stroke and blood clots. A woman’s risk depended on whether she was taking estrogen alone or estrogen plus progesterone. The findings disputed the prior belief that HRT could reduce a woman’s risk of heart disease.

The Danish study points out numerous factors that impact the pros and cons of HRT, including the amount of hormone taken and the timing of use.

SOURCE: Hormone Replacement Therapy › Timing, method of HRT may affect heart attack risk

Researchers analyzed data from 38 observational studies involving more than 2.7 million women to see whether taking non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen, reduced risk of breast cancer. Inflammation may be a risk factor in cancer, the report says.

Earlier studies on NSAIDS in reducing breast cancer risk have shown conflicting results. Reviewers hope that by combining results they may identify trends that individual studies may miss.

NSAIDs work through the suppression of estrogen, which has researchers speculating that the use of NSAIDs may reduce the risk of hormone-positive breast cancer. Hormone-positive breast cancer, also referred to as estrogen receptor (ER)-positive breast cancer, is the most common type of breast cancer and is stimulated to grow from exposure to the female hormones estrogen and/or progesterone, according to the Daily Cancer News –CancerConsultants.com.

According to the report, women who regularly took any type of NSAIDs had a 12 percent reduction of breast cancer risk. While the news is promising, the report urges that women should first consult their healthcare provider before using any NSAIDs, as these medications can have side effects that carry risks that outweigh the benefits against breast cancer.

SOURCE: Hormone Replacement Therapy › anti-inflammatory drugs may reduce breast cancer risk

In 1997, two women – one in Kansas and the other in New York – were becoming frustrated with the lack of beneficial and comprehensive health care information available to them, especially on the topic of menopause. So they teamed together and formed ProjectAWARE.

The mission of this nonprofit organization is to provide “menopausal and pre-menopausal women with complete and comprehensive information regarding all resources, therapies, and research data currently available, so that armed with this knowledge, women can make informed decisions regarding every healthcare option.”

ProjectAWARE, also known as the Association of Women for the Advancement of Research & Education, has since built to a team of eight and, through its website, gives detailed information about hormone replacement therapy (HRT), including synthetic HRT, natural (bio-identical) HRT, and alternatives to hormones, such as herbal remedies.

The site also touches on the possible link between HRT and breast cancer and other serious illnesses, and gives background on studies and trials that have made HRT a controversial subject over the past few years.

One of the best resources I’ve found on the site are the personal, heartfelt stories of women detailing their journey through menopause and beyond. As women, we find strength in numbers. Just knowing that someone else is experiencing the same symptoms or fears as she approaches “the change,” gives us added confidence to tackle the rough road ahead.

SOURCE: Hormone Replacement Therapy › ProjectAWARE answers questions about menopause

For years, HRT was considered the cure-all for menopausal symptoms that range from hot flashes and riding the emotional roller coaster to bone loss and osteoporosis. But a 2002 study by the Women’s Health Initiative (WHI) and funded by the National Institutes of Health stopped women and their doctors in their tracks when the research revealed that the risks of HRT far outweighed and outnumbered the benefits. The WHI report stated that long-term use of estrogen/progestin therapy led to a 26 percent increase in breast cancer, not to mention a laundry list of other serious side effects.

The American Cancer Society suggests women talk with their own doctors before deciding whether HRT is right for them. The organization also suggested women heed the advice of the WHI, which includes not continuing or starting HRT to prevent heart disease; to discuss their risk of heart attack, stroke, blood clots and breast cancer before taking HRT for osteoporosis prevention; and to perform regular breast self-exams and schedule annual mammograms.

Using HRT for the short-term may be a safer alternative, the report states, however, “Given these results, we recommend that clinicians stop prescribing this combination for long term use. ‘Primum non nocere’ [First, do no harm] applies especially to preventive health care.”

SOURCE: Hormone Replacement Therapy › October is breast cancer month; time to evaluate breast health

Prempro and Premarin , along with Provera, which is made by Pfizer, have come under attack in recent years as mounting evidence revealed that the drugs can increase the risk of developing breast cancer. Plaintiffs lodging claims against the drug makers argue that the manufacturers failed to voice sufficient warning about the increased risk of developing breast cancer that the drugs present. Approximately 5,000 women have filed lawsuits against Wyeth, contending that the company’s HRTs (hormone replacement therapies) caused them to develop breast cancer.

A study monitoring 3,400 recipients of Aprela indicated no evidence of increased breast cancer rates, compared with women who received Evista or placebo. Aprela recipients also showed the same relatively lower rates of breast tenderness and pain as Evista and placebo recipients – a significant benefit considering that breast discomfort is the main reason why stop using menopause drugs

Other studies revealed that Aprela recipients experienced better sleep and diminished hot flashes compared to women who were treated with placebo. Increased bone density, improved sexual function, and less vaginal dryness were also evident in late-stage tests of Aprela.

Wyeth will submit Aprela to the FDA for approved use in the second half of 2009. If approved, the drug may provide a better line of treatment for postmenopausal women. Its marketing would also help the company offset continual losses resulting from its Prempro suits.

SOURCE: Hormone Replacement Therapy › Wyeth developing another HRT for menopause

A study published in the January issue of Cancer Epidemiology, Biomarkers and Prevention found that women who used combination hormone therapy for three or more years had a higher risk of lobular cancer.

The study was led by Dr. Christopher Li of the Fred Hutchinson Cancer Research Center and was designed to evaluate the relationship between combination hormone therapy and lobular breast cancers. Previous research indicated that five or more years of combined hormone therapy use was necessary to increase overall breast cancer risk. The study led by Dr. Li found that women who took combined hormone therapy for three years or more had four times the usual risk of lobular breast cancer.

The incidence of invasive lobular cancer rose by 52% in the United States between 1987 and 1999, and cases of ductal-lobular breast cancer rose by 96% during that time. According to Dr. Li, their research “suggests that the use of post-menopausal hormone-replacement therapy, specifically the use of combined estrogen-plus-progestin preparations, may be contributing to this increase.” Following the announcement of the results of the Women’s Health Initiative in July 2002, hormone therapy use fell sharply.

The incidence of breast cancer dropped more than 8% between 2001 and 2004. Beasley Allen law firm has been involved in extensive litigation dealing with hormone therapy and breast cancer. We are convinced that there will be more litigation in this area of concern. Ted Meadows and Melissa Prickett from our firm are handling cases for clients at this time.

SOURCE: Hormone Replacement Therapy › Hormone therapy update

The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices.

Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices.

The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. The second case, involving claims for injuries allegedly caused by Rezulin, a now-withdrawn drug used to treat diabetes, will be heard in February.

Pharmaceutical manufacturers have long complained that the expense of defending injury claims has slowed research into new medications and driven up costs for patients. Because Congress granted the Food and Drug Administration the authority to determine whether products are safe and effective, manufacturers argue that state judges and juries should not be allowed to second-guess the FDA once a product is approved for use.

State damage claims put pharmaceutical makers in a “Catch-22 between complying with FDA regulations on the one hand and still being subject to state liability on the other,” said Rob Clark, a government affairs director for Medtronic Inc., which made the cardiac catheter.

But plaintiffs’ lawyers and consumer groups say that the FDA has approved some drugs and devices based on sloppy or falsified test data, adding that lawsuits are the only way evidence of drug risks or drug maker fraud has come to light.

A report issued Friday by three members of the FDA’s own Science Boardfound that the agency was so poorly organized and short of funds that it could not adequately protect the public from dangerous drugs.

A ruling for Medtronic would “take away the last possible safety net against unfettered corporate misbehavior and negligence,” said Karen Barth Menzies, a Newport Beach lawyer who has represented plaintiffs in cases against drug makers.

Menzies sees these “preemption” cases as a new battlefront in the tort-reform wars in the wake of limits imposed by Congress and state legislatures in recent years on class actions and medical malpractice claims.

Charles Riegel sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. Riegel died in 2004 of causes unrelated to the angioplasty, and his widow took over his claim. Her case was thrown out by a U.S. District Court judge and then by the U.S. Court of Appeals.

The prospect that the high court may bar injury claims for FDA-approved pharmaceuticals helped precipitate the $4.85-billion settlement of Vioxx claims last month, according to lawyers involved in the negotiations.

Lawyers representing plaintiffs who took the popular painkiller insisted on language that would allow the settlement to close and compensation be paid even if the high court sides with Medtronic. Vioxx maker Merck & Co. took the drug off the market in 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976. Widespread injuries reported by women who used the Dalkon Shield intrauterine device and other products had earlier prompted California and a few other states to impose some labeling and design requirements in the absence of federal standards.

The 1976 federal statute specifically said that states couldn’t maintain requirements that were different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims, and device manufacturers didn’t argue that they did until recently, said Allison Zieve, a lawyer with Washington-based Public Citizen Litigation Group who will be arguing for Donna Riegel before the court.

In rejecting the Riegel suit, the lower courts reasoned that if the plaintiffs reached trial and won, the damages would amount to a state “requirement” different from FDA requirements because the complaint depended on state law.

Glenn Lammi, chief counsel with the Washington Legal Foundation, said continuing to allow injury claims under state law could create “a patchwork of rules” governing product design and use that “creates confusion among consumers” and raises costs. The foundation, a group that advocates restrictions on lawsuits, submitted an amicus brief on behalf of the company.

Beyond the issue of whether patients have the right to sue under state law, Medtronic’s Clark insisted the company was not responsible for Riegel’s injuries because his doctor used the catheter improperly, inflating the balloon beyond the pressure specified on the FDA-approved instructions.

Zieve disagrees that the label was adequate, calling the instructions “confusing and misleading.” However, she said the preemption argument was more central to the case, calling it “essentially a get out of jail free card.”

If the court upholds Medtronic’s position, Zieve said, it means that “no matter who messed up, you can’t sue the company.”

December 4th, 2007 by Molly Selvin with Los Angeles Times

SOURCE: Hormone Replacement Therapy › High court may bar claims for FDA-approved drugs

According to the lawsuit filed in St. Clair County Circuit Court, Gray used Prempro from Jan. 19, 1998, through Oct. 15, 2005. She was diagnosed with left breast cancer on Nov. 14, 2005.

They claim the drug was defectively designed and that the defendants failed to warn users of its danger.

“…Defendants failed to perform adequate testing and study HRT (hormone replacement therapy) drugs prior to marketing it or properly analyze and warn based upon studies and testing,” the complaint states.

The defendants failed to warn the plaintiff that use of HRT drugs carried a risk of ovarian cancer.

In a claim for loss of consortium, the lawsuit alleges the marital association of the Grays has been altered causing great mental anguish.

November 26th, 2007

SOURCE: Hormone Replacement Therapy › Prempro user claims drug caused breast cancer

Scharlotte Fitzgerald says she began taking hormone replacement drugs in 1994. In 2001 she was diagnosed with breast cancer.

Fitzgerald and her husband Larry filed a personal injury suit against the drug companies in the Beaumont Division of the Eastern District of Texas on Nov. 2. They are seeking in excess of $75,000 in damages.

“This lawsuit asserts claims for negligence; strict product liability for failure to warn, strict product liability for design defect; and breach of implied warranty against the defendants responsible for the design, manufacture, production, testing, study, inspection, mixture, labeling, marketing, advertising, sales, promotion and/or distribution of those hormone therapy products that caused her breast cancer,” the plaintiffs’ original complaint states.

The plaintiffs’ claim that the defendants had an obligation to provide warnings about risks and side effects of their hormone therapy drugs as soon as it was aware of them. The suit alleges that the drug companies failed to disclose “an increased incidence and risk of strokes, blood clots, heart attacks, breast cancers and ovarian cancer from these drugs.”

Plaintiffs also assert that the defendants made claims regarding health benefits of the drugs and should have known “that these claims were false and misleading.”

The defendants also gave a false impression that adequate pre-marketing clinical testing and research and post-marketing surveillance had been done, the plaintiffs claim.

“Plaintiff would not have ingested the hormone therapy drugs … or would have discontinued their use, or would have used safer alternative methods, had defendants disclosed the true health consequences, risks, and adverse effects, including the increased incidence and risk of breast cancer and other illnesses, caused by their hormone drugs,” the complaint states.

In the first claim against defendants, the plaintiff alleges that the companies were negligent by failing to exercise reasonable care in designing, manufacturing, testing and distributing the hormone replacement drugs.

“Defendants knew or should have known that their hormone therapy drugs caused unreasonable harm and dangerous side effects that many users would be unable to remedy by any means,” the petition states. “Despite this, defendants continued to promote and market their hormone therapy drugs for use by consumers, including plaintiff, when safer and more effective methods of countering the negative health effects of menopause were available.”

The petition also includes claims for strict liability through failure to warn and design defect.

“These hormone therapy drugs were each dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchased them,” the suit says. “They were more dangerous than plaintiff contemplated. The risk of each of these hormone therapy drugs outweighs its utility.”

The companies also breached implied warranty, the suit said, because the sold the drugs as being of “merchantable quality and safe and fit for their intended use.”

Scharlette Fitzgerald is seeking damages to exceed $75,000, attorney fees, costs of suit and other relief that the court may deem just and proper.

Her husband, Larry Fitzgerald is also seeking monetary damages for his loss of spousal services, society and companionship.

SOURCE: Hormone Replacement Therapy › Lawsuit filed over HRT drugs blamed for breast cancer

Earlier this month a jury in Nevada awarded $134 million in a similar case against Wyeth, which is appealing the verdict. Wyeth spokesman Doug Petkus would not comment specifically about the Hesch case, but said it’’s the first lawsuit he’’s heard about since the Nevada judgment.

Sharon Hesch was first prescribed the hormone therapy medication Provera and Premarin in May 1998, her lawsuit says. She switched to only Premarin in January 2001. She was diagnosed with breast cancer in January 2002.

Sharon Hesch alleges the drug companies acted recklessly and without regard to public safety.

“The defendants misled both the medical community and the public at large, including the plaintiff Sharon Hesch, by falsely representing the safety of their products,” her lawsuit says.

In the Nevada case, a jury awarded three women $35 million for expenses, pain and suffering, and added $99 million in punitive damages. Wyeth spokesman Lawrence Stein said it was a flawed verdict in a trial “riddled with errors.”

Petkus said 20 other hormone therapy cases have gone to trial or were otherwise resolved. He said three went in Wyeth’’s favor, two were plaintiff awards that were thrown out by courts, three were dismissed, and 12 were withdrawn by plaintiffs.

October 25th, 2007

SOURCE: Hormone Replacement Therapy › Hormone therapy led to cancer

Minnie Louise Gray and her husband John E. Gray filed an 11-count suit against Wyeth, Inc. over its drug Prempro, which is used by post-menopausal women. The suit also names Walgreen as a defendant for having sold the drug to Gray.

According to the lawsuit filed in St. Clair County Circuit Court, Gray used Prempro from Jan. 19, 1998, through Oct. 15, 2005. She was diagnosed with left breast cancer on Nov. 14, 2005.

The lawsuit claims the drug was defectively designed and that the defendants failed to warn users of its danger.

“…Defendants failed to perform adequate testing and study HRT (hormone replacement therapy) drugs prior to marketing it or properly analyze and warn based upon studies and testing,” the complaint states.

The lawsuit claims the defendants failed to warn the plaintiff that use of HRT drugs carried a risk of ovarian cancer.

In a claim for loss of consortium, the lawsuit alleges the marital association of the Grays has been altered causing great mental anguish.

October 23rd, 2007

SOURCE: Hormone Replacement Therapy › Prempro user claims drug caused breast cancer

For some the menopause can be uncomfortable and distressing. Symptoms can include: hot flushes, night sweats, palpitations, vaginal dryness, urinary tract infections, depression, mood swings, weight gain, memory problems or sore joints. The majority of women however will only suffer hot flushes and irregular menstruation, whilst others may not experience any symptoms at all.

Throughout the last four decades the use of Hormone Replacement Therapy (HRT) has become the conventional treatment for discomfort. HRT involves taking supplements of oestrogen and progesterone or, occasionally, testosterone. The hormones used are either identical to human hormones, are extracted from horse urine or are manufactured synthetic substances.

Whilst it has been shown that long-term use of HRT may help to prevent osteoporosis and bowel cancer, studies have also indicated that the dangers of the treatment may far outweigh the benefits. The greatest concern is a much higher incidence of breast cancer cases, heart attacks, strokes and blood clots in women taking HRT.

Many are now choosing to return to natural remedies to reduce and even prevent menopausal symptoms and there are many simple alterations to your life style that can also make the experience a much more pleasant one.

For instance many plants such as soya, tofu and flax seed contain oestrogen and regular consumption of these foods appears to have the same benefits as hormone replacement therapy. In fact, in areas of the world such as China, Japan, Thailand and India these foods are part of the daily diet and the incidence of unpleasant menopausal symptoms in women is minimal.

Hot spicy foods, smoking, caffeine, stress and alcohol can all exasperate symptoms and bring on hot flushes so all should be avoided or kept to a minimum. Lack of sleep can contribute to depression and mood swings so get plenty of exercise every day and avoid working late and large meals before going to bed.

Certain vitamins and minerals can also help. For example, vitamin B12 can support the nervous system and give you energy whilst vitamin E can alleviate symptoms and is a great antioxidant.

A herbalist or naturopath will also be able to recommend plant extracts that will help your body find its own natural balance. These include wild yam cream, red clover and evening primrose.

In some people hypnosis and self-hypnosis techniques have helped relieve symptoms and tackle problems of low self esteem and body image. XF

October 17th, 2007

SOURCE: Hormone Replacement Therapy › Natural menopause

The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs.

“We got the word out that a lot of women have been injured by this type of behavior by this company,” Rowatt said after the verdict. She said she was “ecstatic” with the award. Lawyers for Wyeth, the largest maker of hormone-replacement therapies, said the company will appeal the verdict.

The three women’s suits, which were combined for trial, are among about 5,300 against Madison, New Jersey-based Wyeth over its menopause drugs. As many as 6 million women took the pills to treat menopause symptoms such as hot flashes and mood swings before a 2002 study highlighted the drugs’ links to cancer.

Annual sales of Wyeth’s hormone-replacement drugs exceeded $2 billion before the 2002 Women’s Health Initiative study, sponsored by the U.S. National Institutes of Health, suggested women using the medicines had a 24 percent higher risk of breast cancer. The drugs, which are still on the market, generated more than $1 billion in sales in 2006.

Ignored Risks

Lawyers for Rowatt, Scofield and Forrester argued in the Reno case that Wyeth officials ignored Prempro’s health risks and failed to properly warn doctors and consumers about the drug’s cancer link to boost profits.

Wyeth’s lawyers insisted the company conducted extensive safety tests on the drugs and warned of the risks through prescription labels and information sheets. The Reno verdict is the company’s fourth trial loss in suits over the drugs.

“The verdict is an extreme aberration,” said Heidi Hubbard, an attorney for Wyeth. “It is inconsistent with the end result of all other hormone-therapy cases tried to date, and is inconsistent with the evidence. We are confident the Nevada Supreme Court will give the flawed verdict careful scrutiny.”

Jurors considered ordering Wyeth to pay more than $1 billion in punitive damages before settling on the lower number, said Emery Pierce, 22, a supervisor for United Parcel Service who served on the panel.

Pierce said jurors were upset that Wyeth used misleading information on its labels for the Premarin and Prempo menopause drugs.

‘Care Enough’

“There’s no way they provided an adequate warning,” the Reno resident said. “They didn’t seem to care enough that breast cancer kills people.”

Having a jury find Wyeth’s conduct warrants a punitive- damage award should be a concern for the company, said Michael Kelly, a Wilmington, Delaware-based lawyer who represents drugmakers in product-liability cases.

“The punitive award shows that the jury found there was a conscious indifference to patient safety,” Kelly said. “That’s not the kind of reputation a pharmaceutical company wants to have.”

The Reno verdict was the fourth loss for Wyeth since lawsuits over the menopause drugs began going to trial in August 2006. It’s the largest verdict so far in the hormone-replacement therapy cases and the eighth-largest verdict of any kind in the U.S. this year, according to Bloomberg data.

Prempro Trials

The company has won two federal-court suits that have come to trial over Prempro and Premarin as well one case filed in state court in Philadelphia. Three other Philadelphia juries found the medicines contributed to the development of breast cancer in women and ordered the company to pay a total of $3 million in damages. Judges later threw out those verdicts.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera to relieve their symptoms. That year, Wyeth combined the two hormones in its Prempro pill after winning the U.S. Food and Drug Administration’s approval of the treatment.

Rowatt, 67, Scofield, 74, and Forrester, 64, all used Wyeth’s hormone replacement drugs for different lengths of time, according to court records. Rowatt was awarded $31 million in punitive damages by the Reno jury, Scofield $33 million and Forrester $35 million.

Rowatt, a retired Defense Department worker, used the drugs for more than seven years. Forrester, a former administrative assistant, used them for more than nine years. Scofield, a homemaker, was on hormone-replacement therapies for 15 years.

‘Deserved This’

All three women sat through the entire five-week trial. After the initial verdict was handed down last week, the trio cried as they hugged Zoe Littlepage, one of their lawyers. “You so deserved this,” the lawyer told them.

The jury initially awarded the plaintiffs $134.5 million, or more than $43 million each. The panel had to reconsider that verdict after Judge Robert Perry learned part of the figure was intended to punish Wyeth for its mishandling of the drugs.

Jurors cut that award to a total of $35.1 million in compensatory damages for the three women after spending several hours reconsidering their verdict on Friday.

Wyeth lawyer Dan Webb today asked Perry to throw out the punitive-damage verdict because of the jury error. The judge refused.

The jury told these three women “that their lives and suffering have value,” Littlepage said. The decision shows “what a courageous Nevada jury thinks of what Wyeth has done.”

According to a company-funded study presented today in Washington, Wyeth’s drug Pristiq, the first non-hormone menopause pill, reduces symptoms such as hot flashes more effectively than placebo. Pristiq was delayed by regulators for additional safety tests.

October 16th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth must pay $134.1 million in menopause drug lawsuit

The company won 15 of the 18 lawsuits that have been tried, according to company information. Two others were settled, and one was in the plaintiff’s favor.

Lawyers for the three women who were awarded more than $120 million in jury awards in Reno have disputed Wyeth’s claims.

Nevada residents Jeraldine Scofield, Arlene Rowatt and Pamela Forrester testified that they developed breast cancer after taking Premarin, an estrogen replacement, and Prempro, a combination estrogen, and progestin to offset the symptoms of menopause.

They claimed in their lawsuit that Wyeth produced a dangerous product, failed to adequately test the drugs and failed to provide warnings about the drugs’ risks.

After two days of deliberations, the jury agreed with the women’s claims and ordered Wyeth to pay $43.5 million each to Scofield and Rowatt, and $47.5 million to Forrester.

The jury will deliberate at 10 a.m. today about punitive damages.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Wyeth fights more than 5,000 hrt lawsuits nationwide

It was the largest award to date against Wyeth, of Madison, N.J., which faces more than 5,000 similar lawsuits across the country in state and federal courts.

The panel deliberated for two days before announcing its verdict late Wednesday in favor of Jeraldine Scofield, 75, of Fallon; Arlene Rowatt, 67, of Incline Village; and Pamela Forrester, 64, of Yerington.

A Wyeth spokesman, Douglas Petkus, said Thursday that the company would have no comment. But in an e-mail message to The Associated Press, he noted that 20 similar cases had gone to trial or been otherwise resolved. Of those, he said, three were resolved in favor of the company, two plaintiff verdicts were set aside by the courts and three cases were dismissed on summary judgment. Twelve other cases were dropped by the plaintiffs before trial, he said.

During the trial concluded here, the women testified that they had started taking Premarin, an estrogen replacement, and Prempro, a combination of estrogen and progestin, to help offset menopausal symptoms, but were taken off the therapy when they developed breast cancer.

Wyeth lawyers said the company sponsored or participated in studies on the risks of breast cancer, and detailed the risks on warning labels included with each bottle of the drug.

Last October, Wyeth reached an undisclosed settlement with a fourth woman who had been part of the lawsuit. That woman, Carol McCreary, was found to have breast cancer in 2001 after taking Prempro for about 33 months. She died in April at 59.

To learn more about the link between hormone replacement therapy and breast cancer, visit www.hrt-legal.com.

October 12th, 2007

SOURCE: Hormone Replacement Therapy › Jury awards 3 women $134.5 million in hormone therapy lawsuit

The jury also must decide whether Wyeth failed to adequately test their drugs Premarin, an estrogen replacement, and Prempro, a combination estrogen and progestin, before putting them on the market and whether it failed to warn doctors about the drugs’ risks.

“Wyeth didn’t do (breast cancer) studies because the results could be embarrassing and could be costly,” Zoe Littlepage, a lawyer for Jeraldine Scofield of Fallon, Arlene Rowatt of Incline Village and Pamela Forrester of Yerington, told the jury.

The company’s decision to produce, market and sell a dangerous product affected thousands of women, and the company should be held responsible, Littlepage said during her closing argument in Washoe District Court.

Wyeth lawyer Heidi Hubbard said microscopic analysis showed the cancers each of the three women suffered are different, and no one can say why they developed. But each woman had a list of risk factors that could have contributed to their diseases.

“So many women get breast cancer, and we don’t know to this day what causes it; and researchers are trying to find the cause so they can find the cure,” Hubbard said.

“This case is about a medication that’s an appropriate treatment option for many women,” she said. “To this day, (the drugs) are the most effective available for menopausal symptoms.”

Scofield, 75, Rowart, 67, and Forrester, 64, began taking hormone replacement drugs years ago to offset hot flashes and other discomforts associated with menopause. But when each developed breast cancer, they stopped the drugs and underwent treatment.

The lawyers for the three women, who have sat in the front row of the courtroom every day of the trial, said Wyeth knew there were links between their drugs and the cancers but ignored the dangers in favor of skyrocketing sales.

The warning labels the company put on the drugs sounded more like reassurances than alarms, Littlepage said. Doctors testified if they knew then what they know now about the breast cancer risks, they never would have prescribed the drugs long-term as the company promoted them, she said.

Dan Webb, another Wyeth lawyer, challenged those claims.

Wyeth helped sponsor or participated in 63 studies to look at whether hormone replacement drugs increased the risk of breast cancer, he said. When the results came in, the company followed a directive from the U.S. Food and Drug Administration and created warning labels that detailed the risks, he said.

“The FDA knows more about research on drugs than the plaintiffs,” Webb said. “When (the women) say we didn’t properly test, it’s not true. Wyeth clearly understood the breast cancer risk and put it on the label.”

The women’s civil lawsuit seeks unspecified damages, but Littlepage told the jurors that they should look at how the company spent its money to promote the drugs when considering an appropriate amount. Those totals were in the millions of dollars.

October 10th, 2007

SOURCE: Hormone Replacement Therapy › Prempro lawsuit goes to the jury

Brett Hendricks, a former sales representative for Wyeth, provided riveting testimony regarding his twenty-one year career with the largest manufacturer of hormone replacement therapy drugs that outlined the organized deception of doctors and patients that plaintiffs contend overstated the benefits of HRT therapy while concealing the risks.

“That’s how we were trained,” Hendricks said. “To offset any bad publicity, we would redirect and emphasize the benefits of the product and say the benefits far outweighed any problems that might be out there.”

On the stand, Hendricks confirmed Wyeth’s marketing strategy that had already been laid out in the millions of pages of documents produced by Wyeth and others in the HRT litigation that has been pending for more than five years. Wyeth sales representatives were encouraged to engage in aggressive, one-on-one sales tactics with prescribing physicians to supplement the manufacturer’s advertising plan which included overselling the benefits of HRT drugs, discrediting scientific studies that raised any questions about safety (especially breast cancer risks), criticizing physicians who chose safer alternative drugs or counseled their patients on the option of not taking any HRT drugs at all, and pushing menopausal women to take combination hormone product drugs from the onset of menopause (or perhaps even before) and to continue taking the drugs throughout the rest of their lives.

In July of 2002, the Women’s Health Initiative (”WHI”) study was published and confirmed what many had long suspected – that Prempro and combination hormone replacement products (including Wyeth’s Premarin taken in combination with Pfizer’s Provera or another progestin such as medroxyprogesterone) are associated with an increased risk of hormone-positive breast cancers as well as other health risks, including heart attacks, strokes, blood clots, and ovarian cancer, etc.

The WHI Study (which was funded by the United States government, after manufacturers of hormone replacement drugs failed to conduct proper studies to evaluate the risks of HRT-induced breast cancer) led to a fundamental shift in the manner in which HRT drugs were prescribed. Today, physicians and patients are being told that HRT is not right for every woman, and instead should only be considered by those for whom the symptoms of menopause are severe and interfering with their lives. In addition, patients have been encouraged to use HRT drugs for the shortest time possible and at the lowest possible doses.

In fact, the Prempro product ingested by most women prior to 2002 no longer exists, and instead was replaced by a lower dose product (although it is not yet known whether a lower dose actually equates to a lower breast cancer risk). There is also a strong movement in the medical community to investigate other drugs for menopausal symptoms and osteoporosis, including SERMs (selective estrogen receptor modulators) and natural or bioidentical hormones that more closely resemble those that are made by a woman’s body. Prempro, for example, includes an estrogen compound derived from the urine of pregnant horses and chemically synthesized progestin (which is a necessary additive since estrogen alone has long been known to cause uterine cancer, but also eliminates many of the benefits that have been shown with use of estrogen alone and increases the risks of breast cancer).

The pharmaceutical industry has long maligned alternative therapies for menopausal patients, but evidence continues to mount that the HRT-induced breast cancer epidemic noted in recent breast cancer registries might have been avoided if women had been given more information in order to make meaningful decisions regarding treatment options years ago.

The Reno HRT trial is expected to last for a few more weeks. Alley, Clark, Greiwe & Fulmer will be trying the first HRT case in Florida in Pinellas County in June of 2008. This will be the first wrongful death claim to be brought to trial in the national litigation. The case was brought on behalf of a Clearwater grandmother who was diagnosed in early 2002 at the age of 59 with hormone-positive lobular breast cancer (the type most strongly associated with use of HRT drugs), just months prior to announcement of the WHI study results. Her cancer was very aggressive and had already spread to brain and bones by that time. After fighting valiantly for several years, she lost her battle and died late last year before her case was scheduled for trial. The lawsuit is now being prosecuted by her loving husband of forty-one years on behalf of her estate and survivors.

October 5th, 2007

SOURCE: Hormone Replacement Therapy › HRT sales rep whistleblower admits improper promotion